Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases

NCT07694817 | Not Yet Recruiting

• 1 other identifier: OSD
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective-prospective study aims to identify the diagnostic parameters most predictive of BSCVA in patients with OSD. Clinical, structural, and biochemical data will be collected from standard-of-care examinations and patient-reported outcome questionnaires. The goal is to determine the most informative biomarkers for visual prognosis, streamline diagnostic workflows, and support individualized management of OSD.

Conditions

Neurotrophic Keratopathy; Cornea Abnormality; Limbal Stem Cell Deficiency (LSCD); Exposure Keratopathy; Cornea Disease; Cornea Inflamed

Outcome Measures

Primary Outcomes (1)

• Best spectacle-corrected visual acuity (BSCVA) measured in logMAR

  Best spectacle-corrected visual acuity will be measured using a standardized Early Treatment Diabetic Retinopathy Study chart at 4 meters after manifest refraction and best spectacle correction. Visual acuity will be reported as logarithm of the minimum angle of resolution. Expected range: -0.3 to 2.0 logMAR. Higher logMAR values indicate worse visual acuity.

  Baseline, 6, and 12 months

Secondary Outcomes (15)

• Maximum keratometry (K max) measured by corneal tomography

  Baseline, 6, and 12 months

• Central corneal thickness (CCT) measured by corneal tomography

  Baseline, 6, and 12 months

• Corneal nerve density measured by in vivo confocal microscopy

  Baseline, 6, and 12 months

• Corneal sensitivity measured by Cochet-Bonnet esthesiometer

  Baseline, 6, and 12 months

• Tear fluid interleukin-1 beta (IL-1β) concentration

  Baseline, 6, and 12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll adult patients (≥18 years old) of both sexes, representative of the population affected by OSD. No restrictions will be applied regarding ethnicity or socioeconomic background

You may qualify if:

• The participant is willing and able to provide written informed consent for study participation (prospective cohort).
• Clinically confirmed diagnosis of OSD, including but not limited to inflammatory keratopathies, neurotrophic keratopathy, exposure keratopathy, limbal stem cell deficiency, post-surgical or post-traumatic corneal alterations.
• Measurable BSCVA obtained through standardized manifest refraction and ETDRS chart testing at baseline.
• Available dataset for the diagnostic tests required by the study (e.g., corneal topography, pachymetry, confocal microscopy, corneal sensitivity testing, slit-lamp imaging, tear cytokine analysis, impression cytology).
• Willingness and ability to attend follow-up visits and complete all study-related procedures according to the study schedule.

You may not qualify if:

• Change of retinal, optic nerve, or macular pathology that may affect best spectacle-corrected visual acuity independently of the cornea or ocular surface (e.g., age-related macular degeneration, diabetic macular edema, optic neuropathy) in the period of study
• History of intraocular or corneal surgery within 3 months prior to baseline evaluation.
• Active intraocular inflammation, glaucoma with uncontrolled intraocular pressure, or corneal conditions not compatible with accurate imaging or measurement (e.g., severe scarring, leukoma).
• Uncontrolled systemic diseases that may impair vision or corneal health (e.g., advanced diabetes, autoimmune disease in active phase).
• Inability or unwillingness to attend follow-up visits or complete study assessments.
• Pregnant or breastfeeding women will not be enrolled, as hormonal fluctuations can alter tear film and ocular surface physiology

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Limbal Stem Cell Deficiency; Corneal Diseases; Keratitis

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Giulio Ferrari, MD, PhD, Professor

CONTACT

+390226436186; ferrari.giulio@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)